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Nebulizer, Aerosol mask (Pediatric)
EUDAMEDClass IIb (EU MDR)
Ref 8905-0-50Model Salter Nebulizers
by Salter Labs
Identity
- Trade Name
- Nebulizer, Aerosol mask (Pediatric) EUDAMED
- Model / Reference
- Salter Nebulizers EUDAMED8905-0-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411890113 EUDAMED
- Basic UDI-DI
- 0607411TF20013d_NebEE EUDAMED
- Unit of Use DI
- 00607411890116 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nebulizer, Aerosol mask (Pediatric) by Salter Labs — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0607411TF20013d_NebEE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Salter Labs
- EUDAMED SRN
- US-MF-000007934
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 398511ef-ebe9-4b33-847c-7d542184c6a3 61 fields · synced Jun 18, 2026